Structure Function Claims: What Supplement Brands Can (and Can't) Say

One wrong word on your label can turn your dietary supplement into an unapproved drug overnight.

The difference between "supports healthy cholesterol levels" (compliant structure/function claim) and "reduces cholesterol" (illegal disease claim) isn't semantic hairsplitting. It's the line between a legal product and an FDA warning letter.

In Q2 2025 alone, FDA issued at least five social media-related warning letters to supplement brands. The agency now uses AI-powered surveillance to scan YouTube transcripts, Instagram posts, and website claims for violations. FTC recently wrapped up a seven-year lawsuit against Prevagen for misleading memory claims. And a company called Defyned Brands pled guilty to distributing misbranded supplements, agreeing to a $4.5 million forfeiture.

The stakes are real. The rules, while strict, are navigable.

This guide explains what structure/function claims are, how they differ from FDA health claims, what substantiation you need, and how to avoid the compliance mistakes that trigger enforcement action.

Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. They were codified by the Dietary Supplement Health and Education Act of 1994 (DSHEA) and represent the primary legal pathway for supplement brands to communicate product benefits.

This is why understanding the difference between structure/function claims and FDA health claims is critical: the wrong classification can reclassify your entire product.

Unlike health claims (which require FDA pre-approval), structure/function claims don't require permission. You just need substantiation and a 30-day notification.

Examples of Compliant Structure/Function Claims

• "Helps maintain healthy cholesterol levels"
• "Supports bone strength"
• "Helps maintain proper joint function"
• "Supports memory"
• "Helps alleviate chronic constipation"
• "Alleviates occasional constipation"
• "Promotes sexual arousal and performance"
• "Helps maintain proper immune function"
• "Helps reduce stress and tension"
• "Mild memory loss associated with aging"
• "Noncystic acne"
• "Mild mood changes, cramps, and edema associated with the menstrual cycle"

These claims work because they describe how a nutrient affects normal structure or function. They don't claim to diagnose, mitigate, treat, cure, or prevent disease.

According to 21 CFR 101.93, a statement becomes a disease claim if it claims (explicitly or implicitly) that the product has an effect on a specific disease or class of diseases, or on the characteristic signs or symptoms of a disease.

Words like "prevent," "mitigate," "diagnose," "cure," or "treat" would be disease claims if the context implies an effect on disease. But here's the catch: even innocent-looking words like "restore," "support," "maintain," "raise," "lower," "promote," "regulate," or "stimulate" can create an implied disease claim depending on context.

Examples of Prohibited Disease Claims

• "Treats Alzheimer's disease" (explicit disease claim)
• "Cures cystic acne" (explicit disease claim)
• "Prevents severe depression" (explicit disease claim)
• "Inhibits platelet aggregation" (characteristic sign of cardiovascular disease)
• "Reduces cholesterol" (characteristic sign of cardiovascular disease)
• "Relieves ulcers" (though "helps maintain digestion" is acceptable)

A claim that a milk product "builds stronger bones" is a structure/function claim because it describes an effect on the body's structure. But "prevents osteoporosis" is a disease claim.

If FDA determines your product makes disease claims, it may consider the supplement an adulterated or misbranded drug, unless you have FDA approval to market it as a drug. That's a multi-million dollar, multi-year regulatory pathway.

Understanding the four types of claims is essential for compliance strategy.

1. Structure/Function Claims

Regulatory pathway: No FDA pre-approval required. Requires 30-day notification and disclaimer.

Standard of evidence: Manufacturer must have substantiation that claims are truthful and not misleading (competent and reliable scientific evidence).

Key requirement: Substantiation must exist before making the claims. The 30-day notification doesn't create the legal right to make claims; the evidence does.

2. Authorized Health Claims

Regulatory pathway: Must be approved by FDA regulation based on "Significant Scientific Agreement" (SSA) standard.

Standard of evidence: Requires petition to FDA demonstrating significant scientific agreement among qualified experts. The SSA standard provides a high level of confidence in the validity of the substance/disease relationship.

3. Qualified Health Claims (QHCs)

Regulatory pathway: FDA issues a "Letter of Enforcement Discretion" specifying how claims may be used. FDA does not "approve" qualified health claims.

Standard of evidence: "Credible evidence." Some scientific evidence exists but not enough to satisfy the full health claim standard.

Required disclaimer: Must include qualifying language that accurately describes the level of scientific evidence supporting the claim.

QHC disclaimers are categorized into different levels (B, C, D) based on evidence strength. Weaker evidence requires more conservative disclaimer language. For example:

• Category B (moderate evidence): "Some scientific evidence suggests that..."
• Category C (low evidence): "Very limited and preliminary scientific research suggests..."
• Category D (minimal evidence): "Although there is scientific evidence supporting this claim, the evidence is not conclusive."

The weaker your evidence, the more hedged your claim language must be.

Recent examples include EPA and DHA Omega-3 consumption and risk of hypertension/coronary heart disease (2025), yogurt and reduced risk of Type 2 diabetes (2024), and high flavanol cocoa powder and cardiovascular health (2023).

The qualified health claim pathway emerged from First Amendment litigation after courts determined FDA's refusal to approve certain claims violated manufacturers' free speech rights.

4. Nutrient Content Claims

Regulatory pathway: Must comply with FDA regulatory definitions for specific terms.

Examples: "High in calcium," "Low sodium," "Good source of fiber," "Reduced fat."

These claims are straightforward but strictly defined. You can't call something "high in calcium" unless it meets FDA's quantitative threshold.

In 2025, FDA finalized a rule updating the "healthy" nutrient content claim to align with current nutrition science and the Dietary Guidelines for Americans. This update modernizes which products can use the "healthy" designation based on contemporary understanding of nutrition, affecting how brands in categories like plant-based proteins, nuts, seeds, and certain oils can position themselves.

Here's what many brands get wrong: the 30-day notification is not pre-approval. It's a procedural requirement.

According to DSHEA, structure/function claims don't require FDA pre-market approval, but notification with the text of the claim must be submitted to FDA no later than 30 days after first marketing the supplement with the claim.

Required Information

Your notification must include:

• Exact text of each claim being made
• Name and address of the brand owner/distributor
• Product name (including brand name)
• Statement certifying the claim is truthful and not misleading
• Copy of the label
• Signature of a responsible individual who can certify accuracy and that the firm has substantiation

You must have substantiation before making claims. The notification doesn't create the legal right; the substantiation does.

Submission Methods

FDA encourages electronic submission via the CFSAN Online Submission Module (COSM) ePortal. As of October 19, 2019, notifications are no longer accepted via the FURLS portal.

Written submissions can also be mailed to FDA.

Here's a risk worth noting: FDA publicly posts all submitted claims. That means competitors, consumers, and watchdog groups can flag noncompliance.

FDA Review

FDA reviews notifications in the order received, typically taking up to one month (though sometimes longer). FDA does not "approve" structure/function claims. The notification is procedural, not a pre-market approval mechanism.

Consequence of non-submission: Failure to submit notification can result in the product being considered misbranded.

Most brands either get serious or get in trouble at this stage.

FTC defines "competent and reliable scientific evidence" as:

"Tests, analyses, research, or studies that (1) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and (2) are generally accepted in the profession to yield accurate and reliable results."

Additionally, the research must be "sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true."

The RCT Standard

As a general matter, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical trials (RCTs) to meet the competent and reliable scientific evidence standard.

There is no set number of RCTs required. But FTC emphasizes that replication in a second study by independent researchers reduces the chance that results may be influenced by unanticipated biases. An additional independently conducted study to corroborate findings provides much greater confidence in validity.

Quality over quantity matters, but you can't claim one study is sufficient without explaining why replication isn't feasible.

What Is NOT Sufficient Evidence

According to FTC guidance, the following are not generally considered competent and reliable scientific evidence:

• Animal studies
• In vitro studies (test tube/laboratory studies)
• Epidemiological or observational studies (with limited exceptions)
• Anecdotal evidence (customer testimonials, individual experiences)
• Public health recommendations and advisories

Limited exception: In cases where high-quality epidemiological evidence is considered an acceptable substitute by experts in the field and RCTs aren't feasible, FTC will accept it.

Evaluating the Totality of Evidence

Here's where brands get nailed: cherry-picking studies.

Advertisers must consider all relevant well-conducted research relating to the claimed benefit. You can't focus only on research that supports an effect while discounting research that doesn't.

Four key attributes of acceptable evidence:

• Unbiased evidence with no personal or financial conflict of interest
• Expertise from studies conducted by experts in the field
• Scientific data (anecdotal evidence like testimonials don't count)
• Consideration of the totality of evidence

If some studies show an ingredient works while others do not, you must explain why. Selectively citing only favorable research while ignoring studies with negative or neutral results can be considered misleading.

Any statistically significant results must translate to a benefit that is clinically meaningful for consumers.

Study Design Requirements

To substantiate claims, pay attention to:

• 1: Product match: The product ingredient must be the same as the ingredient used in the study. For botanicals, the plant part(s) and extraction methods are critical.
• 2: Dose relationship: The product should contain the same dose (or a justified effective dose) as used in clinical trials.
• 3: Population match: The study population should be relevant to the target consumer population. Recent guidance has revisited the definition of "healthy" participants in substantiation trials.
• 4: Study quality: Well-designed clinical trials should be peer-reviewed and published in reputable journals.

Evidence Documentation

You must keep substantiation on file in case FDA or FTC requests it. Your evidence dossier should include:

• Complete study protocols
• Study results and statistical analyses
• Citations to published articles
• Discussion of methodology and relevance to the product
• Assessment of the totality of evidence

This isn't optional. It's the foundation of your compliance defense.

Let's talk about what gets brands in trouble.

Enforcement Trends (2024-2025)

FDA and FTC continue aggressive enforcement against supplement disease claims, with increasing use of technology to monitor digital marketing.

In Q2 2025, at least five social media-related warning letters were issued, with most referencing linking to a shopping cart ("commercial bridge"). Key takeaway: If there's no link to commerce, likelihood of receiving a warning letter decreases significantly.

FDA has cited statements from the audio of embedded video posts. Advanced tech tools are being used to detect disease-related claims on websites and social media platforms, including YouTube transcripts.

Recent Warning Letter Examples

C & A Naturistics (March 4, 2025):

Warning letter issued by CDER for an unapproved drug/misbranded product. FDA stated their dietary supplement was actually a drug based on disease claims made. This case shows that even if you call your product a "dietary supplement," FDA will reclassify it based on how you market it.

Social Media Enforcement

Facebook and Instagram are where the majority of social media disease claims are cited. Claims made in YouTube videos and in the "About" section of YouTube channels have also been cited in recent warning letters.

In May 2025, FDA issued Sprout Pharmaceuticals a warning letter for false or misleading claims made by the CEO on her personal Instagram account. The post touted benefits but left out crucial safety information and important details for the indicated population.

Key compliance requirement: Influencers must disclose material connections (payment, free products) and ensure statements are truthful and substantiated.

CBD and Delta-8 Enforcement

In Q2 2025, FDA issued four warning letters related to CBD and delta-8 products, including three letters addressing CBD animal products that cite high-risk disease claims such as seizure prevention.

FDA cited companies for pins and social media titles like "Using CBD for Dog Diarrhea Works," "CBD for Dogs with Epilepsy," and "CBD & Skin Tumors in Dogs EXPLAINED."

In July 2024, federal entities jointly issued five warning letters to companies selling delta-8 THC products in deceptive packaging, with FTC also warning for unfair and deceptive marketing practices.

Disease Claims Disguised as Structure/Function Claims

This is a common violation pattern: using characteristic signs or symptoms of a disease creates an implied disease claim, even without naming the disease.

Examples of implied disease claims:

• "Inhibits platelet aggregation" (implies cardiovascular disease prevention)
• "Reduces cholesterol" (characteristic sign of cardiovascular disease)
• "Treats cognitive decline" (implies Alzheimer's/dementia treatment)

In a 2012 HHS Office of Inspector General study, 7% of supplements lacked the required disclaimer, and 20% included prohibited disease claims on their labels. That's one in five supplements on shelves violating the disease claim prohibition.

Manufacturing Violations (CGMP)

When FDA inspects facilities that manufacture, process, pack, or hold dietary supplements and finds violations, they issue Form 483 listing observations. If the response is inadequate or not provided within 15 days, the 483 escalates to a Warning Letter.

Common CGMP violations that trigger enforcement:

• Not establishing ingredient specifications to ensure purity, strength, and composition
• Manufacturing control lapses, including contamination
• Sterilization failures
• Inadequate packaging

These violations have nothing to do with your claims, but they can get your product pulled from shelves just as quickly. In December 2022, Quality Supplement Manufacturing, Inc. received a warning letter for CGMP violations that had nothing to do with marketing language.

Under 21 CFR Part 111, manufacturers must prepare and follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size to ensure uniformity from batch to batch. Quality control testing must determine compliance with specifications for identity, purity, strength, composition, and contamination limits.

Major FTC Enforcement Actions

Prevagen (2024):

Following seven years of litigation including a jury trial, the court ordered Quincy Bioscience to cease making claims about Prevagen that mislead Americans concerned about memory loss.

This case demonstrates FTC's willingness to pursue lengthy, expensive litigation for deceptive supplement claims.

Roca Labs (2018):

A federal court granted the FTC's request for summary judgment over allegations Roca made baseless weight-loss claims for its products. The case demonstrates FTC's success in litigation when substantiation is weak or nonexistent.

Iovate Health Sciences (2010):

FTC required a major marketer of dietary supplements to pay $5.5 million to settle charges that it falsely advertised that its supplements could help consumers lose weight and treat or prevent colds and other illnesses.

Health Research Laboratories (2022):

FTC finalized an administrative consent order permanently banning two Texas-based companies and their owner from advertising or selling dietary supplements, and from making claims that their products treat, cure, or reduce the risk of disease. This is the nuclear option: complete industry ban.

Defyned Brands (2024):

Pled guilty to distributing misbranded dietary supplements. Agreed to $4.5 million forfeiture.

This case shows that supplement violations can escalate beyond civil enforcement to criminal charges.

Let's talk about what actually goes on your label.

Supplement Facts Panel Format

Title requirements:

• The title "Supplement Facts" must be in bold, larger than any other text in the panel
• Must span the full width whenever practical
• Panel must be enclosed in a box using hairlines

Font and style requirements:

• Single, easy-to-read type style
• Text in black or one color, printed on white or neutral contrasting background
• Upper- and lowercase letters (small packages may use all uppercase)
• Title and headings must be bolded
• Information must be in uniform type size no smaller than 8 point
• Type size no smaller than 6 point may be used for column headings and footnotes

Serving Size Requirements

Serving size must be expressed using a term appropriate for the form of the supplement: "Tablets," "Capsules," "Packets," "Teaspoonfuls."

Servings per container must be listed under serving size, except when stated in the net quantity of contents declaration. The Supplement Facts panel must display "Amount Per Serving" and "% Daily Value" as column headings, with serving size placement aligned on the left side under the "Supplement Facts" title.

Daily Value (DV) Information

Daily Values are the recommended amounts of nutrients to consume or not to exceed each day. The %DV shows how much a nutrient in a single serving contributes to your daily diet.

Example: If the DV for a certain nutrient is 300 micrograms (mcg) and a supplement has 30 mcg in one serving, the %DV would be 10%.

Required Label Elements

All supplement labels must include:

• Supplement name
• Net quantity of contents
• Direction for use
• Warning statements (if any)
• Supplement Facts panel
• List of ingredients
• Name and address of manufacturer, packer, or distributor

Missing any of these elements can result in the product being considered misbranded, even if your structure/function claims are perfectly compliant.

DSHEA Disclaimer Requirements

Required text for structure/function claims:

"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Here's what many brands don't realize: FDA isn't the only watchdog.

Regulatory Structure: FDA vs FTC Jurisdiction

Pursuant to an MOU between FDA and FTC:

• FDA has primary responsibility over claims that appear on labeling
• FTC has primary responsibility for claims made in advertising

Both agencies require health-related marketing to be truthful and substantiated.

Brands often assume that FDA health claims rules don't apply to advertising, but FTC law makes no such distinction. Whether your claim appears on a label or in a Facebook ad, it must be substantiated.

Key difference: FTC advertising law applies to all products and claims. Unlike FDA law, FTC law makes no bright-line distinctions between categories of health-related products or claims.

FTC's position on disclaimers: FDA-mandated disclaimers, such as the DSHEA disclaimer for dietary supplements, do not cure an otherwise misleading health-benefit claim.

National Advertising Division (NAD) Self-Regulation

NAD is a self-regulatory body operated by BBB National Programs that assesses the truth and accuracy of claims made in national advertising.

While participation is voluntary, refusal to participate or comply results in FTC referral. And NAD referrals receive priority treatment from FTC, so an advertiser can expect a call from an FTC attorney assigned to the referral.

NAD Case Example: Trigosamine Fast Acting (Patent Health):

Patent Health made "speed" claims for Trigosamine Fast Acting based on a "six-minute walk test" from a single clinical study. NAD found claims were not supported and recommended discontinuance. Patent Health failed to modify claims, leading to FTC referral.

This illustrates a common substantiation failure: relying on a single study without replication.

Optimmuner Plus (Hypernaturals, LLC):

NAD recommended the company discontinue express health-related claims that Optimmuner Plus would "provide invaluable help to people suffering from terminal or autoimmune disease" and "boost the immune system." The company failed to submit a substantive response, so NAD referred the case to both FTC and FDA.

Focused Mind, Jr. (Creekside Natural Therapeutics):

Creekside failed to file an Advertiser's Statement either agreeing to comply with NAD's recommendations or appealing the decision. NAD referred the matter to FTC for possible enforcement action.

The pattern is clear: NAD gives you a chance to self-correct. If you ignore it, FTC gets involved, and they don't offer second chances.

If you're planning global distribution, you need to understand that U.S. structure/function claims don't translate internationally.

EU: EFSA Health Claims

In the EU, health claims are approved by the European Food Safety Authority (EFSA) and authorized by the European Commission under Regulation (EC) No 1924/2006.

Key difference from U.S.: Only claims listed on the EU Register of Nutrition and Health Claims can be used in marketing or labeling. Pre-approval is required before making any claim. Claims implying disease prevention or treatment remain prohibited.

Article 13.1 Authorized Claims

Article 13(1) health claims are supported by generally accepted scientific evidence and make up the majority of approved claims. Example: "Calcium contributes to normal muscle function."

Between July 2008 and March 2010, EFSA received 4,637 health claims for evaluation. The agency published 125 scientific opinions covering more than 900 claims. As of 2023, only around 260 had been approved by the European Commission for use.

That's a rejection rate exceeding 90%.

EFSA estimates around 70-90% of evaluated claims have been rejected due to lack of scientific evidence. Since the framework was implemented in 2007, EFSA has authorized just 267 health claims out of over 2,300 submissions.

Successfully authorized claims are typically associated with vitamins (C, D, E, A, B5, B6, B12, folic acid), minerals (zinc, copper, iron, calcium, iodine), plant sterols and stanols, oat and barley beta-glucans, cocoa flavanols, and red yeast rice (cardiovascular health).

The Botanical Claims Wall

Brands have three options:

• Limit claims to vitamin/mineral ingredients (the only reliable path)
• Use "on-hold" claims (technically allowed but not approved; can be banned at any time once the EU Commission finalizes its position)
• Avoid health claims entirely in EU markets

If your formulation relies on botanical ingredients for its primary benefit, EU expansion may require a completely different product strategy. The main reason for rejection is typically insufficient clinical evidence.

UK: Post-Brexit Regulations (MHRA)

Since Brexit, Great Britain has established its own regulatory framework. Health claim approval is managed by the Nutrition and Health Claims Committee (NHCC), not EFSA.

All health and nutrition claims approved by EFSA (up until December 31, 2020) have been automatically adopted into UK law. Only claims listed on the GB Register can be used in marketing or labeling.

The Medicines and Healthcare products Regulatory Agency (MHRA) decides whether a product should be classified as a medicine if claims cross the borderline. Applicants are recommended to complete a Medicines Borderline Advice Form prior to submitting a health claim.

Northern Ireland remains aligned with EU regulations under the Northern Ireland Protocol and continues to follow EFSA guidelines.

GCC: Saudi Arabia SFDA

Saudi Arabia's Saudi Food and Drug Authority (SFDA) regulates health and nutrition claims under SFDA.FD 2333 "Requirements for Health and Nutrition Claims."

Saudi Arabia is a reference country for the Gulf Cooperation Council (GCC) and MENA region regarding food supplement regulations.

Prohibited claims:

• Weight loss claims
• Endorsements by individual health professionals
• Disease prevention or cure claims
• Unsubstantiated statements
• Misleading or fear-inducing claims

Registration Requirements

All imported and locally manufactured food supplements must be registered in Saudi Arabia's electronic food registration system and obtain a registration certificate before market launch. There are no exceptions; you cannot sell in GCC markets without pre-registration.

Required documentation includes:

• Product information and ingredients
• Country of origin
• Shelf life
• Label (in Arabic)
• Testing report
• Halal certificate (for specific product categories)

The product name shall be "food supplement" with an indication of the category(ies) of nutrients or of the individual vitamin(s) and/or mineral(s) contained in the product.

Supplement brands face a compliance gauntlet that combines scientific rigor, regulatory expertise, and international coordination. Most brands either:

• Avoid claims entirely (leaving marketing potential on the table)
• Make aggressive unsubstantiated claims (risking enforcement)
• Spend months on internal research (slowing time-to-market)

Common brand mistakes that trigger enforcement:

• Insufficient substantiation (relying on animal studies or anecdotal testimonials instead of human RCTs)
• Cherry-picking evidence (citing only favorable studies while ignoring conflicting data)
• Implied disease claims (using characteristic signs/symptoms without realizing it creates a disease claim)
• Social media violations (making disease claims on Instagram/YouTube linked to e-commerce)
• Missing disclaimers (7% of supplements lack required DSHEA disclaimer per HHS OIG study)
• Dose mismatch (product contains different dose than clinical trial substantiation)
• Ingredient mismatch (product ingredient differs from study ingredient)
• Failure to notify FDA (missing the 30-day notification deadline)
• CGMP violations (facilities lack proper specifications, controls, or documentation)

Ceuvita offers three pathways depending on where you are in the product development cycle:

Formulation Audit ($500/SKU)

For existing products. We review your formulation against your current claims to identify:

• Dose mismatches between product and available clinical evidence
• Implied disease claims in marketing materials
• Risk level of FDA/FTC enforcement action
• Opportunities to strengthen substantiation or adjust claims

Standard License Pack ($7,500)

For new products launching in U.S. markets. Includes:

• Evidence-based formulation: Ingredient selection and dosing based on available RCT literature
• Substantiation dossier: Compiled package of relevant human clinical trials with totality of evidence assessment
• Structure/function claims: Compliant claim development that avoids disease claim triggers
• 30-day FDA notification documentation: Ready-to-submit materials
• Supplement Facts panel: Design per 21 CFR 101.36
• Trust Mark credential: Third-party verification that signals compliance rigor to consumers and meets marketplace requirements

Delivery: 5-15 days. You own everything; no manufacturing lock-in, no ongoing royalties.

Global License Pack ($15,000)

For brands planning international distribution (EU, UK, GCC). Everything in Standard Pack, plus:

• EFSA compliance navigation: Identification of authorized vitamin/mineral claims; advice on botanical "on-hold" claims and MHRA borderline classification
• SFDA claims review: Compliance under SFDA.FD 2333 prohibited claims rules
• Halal certification guidance: Ingredient sourcing, testing requirements, approved certification bodies (ESMA, GAC, JAKIM)
• Arabic labeling support: Translation and formatting per GCC requirements
• Single formulation strategy: One product design that works across U.S., EU, UK, and GCC markets

The answer isn't to avoid claims. It's to make the right claims, backed by the right evidence, documented the right way.